SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
1 other identifier
interventional
143
1 country
33
Brief Summary
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 major-depressive-disorder
Started Oct 2009
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
October 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2011
CompletedResults Posted
Study results publicly available
April 6, 2012
CompletedJune 8, 2021
May 1, 2021
1.5 years
September 25, 2009
February 7, 2012
May 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Baseline and week 9
Secondary Outcomes (14)
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)
Baseline and week 9
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF
Baseline and week 9
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint
Baseline and up to 9 weeks/Endpoint
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Baseline
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint
Up to 9 weeks/Endpoint
- +9 more secondary outcomes
Study Arms (2)
Active
EXPERIMENTALSPD489
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
Eligibility Criteria
You may qualify if:
- Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression
You may not qualify if:
- Current co-morbid psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (33)
Sun Valley Research Center
Imperial, California, 92251, United States
Pharmacology Research Center
Los Alamitos, California, 90720, United States
Excell Research
Oceanside, California, 92056, United States
Neuropsychiatric Resesarch Center of Orange County
Santa Ana, California, 92701, United States
Connecticut Clincal Research
Cromwell, Connecticut, 06416, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Amit Vijapura, MD
Jacksonville, Florida, 32256, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Atlanta Institute of Medicine & Research
Atlanta, Georgia, 30328, United States
Carman Research
Smyrna, Georgia, 30080, United States
Joliet Center for Clinical Research
Joliet, Illinois, 60435, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
AccelRx Research
Fall River, Massachusetts, 02721, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301, United States
PsychCare Consultants Research
St Louis, Missouri, 63128, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68510, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Richard H. Weisler, MD, PA & Associates
Raleigh, North Carolina, 27609, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45242, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Paramount Clinical Research
Bridgeville, Pennsylvania, 15017, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Bayou City Resesarch, LTD
Houston, Texas, 77007, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
University Hills Clinical Research
Irving, Texas, 75062, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
Wharton Research Center
Wharton, Texas, 77488, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Related Publications (1)
Madhoo M, Keefe RS, Roth RM, Sambunaris A, Wu J, Trivedi MH, Anderson CS, Lasser R. Lisdexamfetamine dimesylate augmentation in adults with persistent executive dysfunction after partial or full remission of major depressive disorder. Neuropsychopharmacology. 2014 May;39(6):1388-98. doi: 10.1038/npp.2013.334. Epub 2013 Dec 6.
PMID: 24309905DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
October 29, 2009
Primary Completion
April 18, 2011
Study Completion
April 18, 2011
Last Updated
June 8, 2021
Results First Posted
April 6, 2012
Record last verified: 2021-05